Back to resultsNeuromodulation in MS Using Translingual Stimulation (NeuroMSTraLS)
Primary Purpose
Multiple Sclerosis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PT plus translingual stimulation device
PT plus translingual stimulation control device
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring physiotherapy, walking and balance, neurorehabilitation, non-invasive cranial nerve neuromodulation
Eligibility Criteria
Inclusion Criteria:
- confirmed diagnosis of multiple sclerosis
- gait deficit due to MS but still able to walk (EDSS less than 6.5, PDDS 3-6)
- older than 18 and less than 70 years of age
- agree to the study time commitment.
Exclusion Criteria:
- currently attending physical rehabilitation for walking and/or balance training,
- currently already functional community ambulators (gait speed>120cm/s)
- contra-indications to the use of translingual electrical stimulation (active or suspected malignant tumor; recent bleeding or open wounds in mouth; women who are pregnant, or sensitivity to nickel, gold or copper)
Sites / Locations
- Memorial University of Newfoundland
- University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PT+ Device
PT + Control Device
Arm Description
PT plus translingual stimulation device PoNS device will be used to deliver trans-lingual electrical stimulation. The stimulation will be delivered while the participants engages in evidence-based physiotherapy for walking and balance.
PT plus translingual stimulation control device Control device will be used. Participants will wear device while engaging in evidence-based physiotherapy for walking and balance.
Outcomes
Primary Outcome Measures
Timed 25 foot walk test (T25FWT)
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. Time to complete the T25FWT, and walking seed will be calculated. A lower time and faster walking speed indicates better walking performance
Dynamic Gait Index (DGI)
This scale has 8 conditions that an individual walks in (e.g. normal, head turns, change in speed, pivot, stairs). Performance for each condition is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best score on the DGI is 24, and a higher score means less walking impairment.
Secondary Outcome Measures
Multiple Sclerosis Impact Scale (MSIS-29)
This is a 29 item self-reported questionnaire - 20 items deal with physical state and 9 with psychological. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where a larger number (e.g. closer to 100) indicates greater impact of disease on daily function.
Fatigue Scale for Motor and Cognitive Functions
This is a 20-item self-reported questionnaire, a Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). Two subscales (mental and physical fatigue) can be made as 10 questions relate to motor fatigue and 10 to cognitive fatigue. A higher score means the individuals is more affected by fatigue.
Short From 36 Health Survey Questionnaire (SF-36)
This is a self-reported questionnaire used to rate health related quality of life. Eight health concepts are covered in 36 questions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The 36 items are rated using a number of different scales and an intricate formula is used to calculate a final score. A high score defines a more favorable health state
Multiple sclerosis walking scale - 12 item (MSWS-12)
This is a 12 item self-reported questionnaire where participants rate each item from 1-5, giving a total out of 60, and then transforming this to a scale with a range from 0 to 100%.
Higher scores indicate a greater impact on walking than lower scores.
Full Information
NCT ID
NCT05275049
First Posted
November 28, 2021
Last Updated
March 9, 2022
Sponsor
University of Saskatchewan
Collaborators
Memorial University of Newfoundland
1. Study Identification
Unique Protocol Identification Number
NCT05275049
Brief Title
Neuromodulation in MS Using Translingual Stimulation
Acronym
NeuroMSTraLS
Official Title
Translingual Stimulation Combined With Physiotherapy to Improve Walking and Balance in Multiple Sclerosis: an RCT
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
July 5, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Memorial University of Newfoundland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The overarching aim of this study is to examine if there is additional benefit to adding trans-lingual electrical stimulation to physiotherapy aimed at improving walking and balance in people with multiple sclerosis (MS).
Detailed Description
This is a two arm, participant-blinded, interventionist blinded, and research assessor-blinded RCT Participants with walking problems due to MS (Patient Determined Disease Steps PDDS 3-6) will be randomized 1:1 after baseline assessment stratified into 2 arms (lower walking disabilities PDDS 3+4, and higher walking disabilities PDDS 5+6) Following a 14 week balance and walking training intervention, participants will be instructed to continue to exercise independently according to the evidence-based Physical Activity Guidelines in MS for a subsequent 12 weeks. They will be reassessed at the end of that time (FOLLOW-UP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
physiotherapy, walking and balance, neurorehabilitation, non-invasive cranial nerve neuromodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PT+ Device
Arm Type
Experimental
Arm Description
PT plus translingual stimulation device PoNS device will be used to deliver trans-lingual electrical stimulation. The stimulation will be delivered while the participants engages in evidence-based physiotherapy for walking and balance.
Arm Title
PT + Control Device
Arm Type
Active Comparator
Arm Description
PT plus translingual stimulation control device Control device will be used. Participants will wear device while engaging in evidence-based physiotherapy for walking and balance.
Intervention Type
Combination Product
Intervention Name(s)
PT plus translingual stimulation device
Intervention Description
PoNS device will be used to deliver trans-lingual electrical stimulation. The stimulation will be delivered while the participants engages in evidence-based physiotherapy for walking and balance.
Intervention Type
Combination Product
Intervention Name(s)
PT plus translingual stimulation control device
Intervention Description
Control device will be used. Participants will wear device while engaging in evidence-based physiotherapy for walking and balance.
Primary Outcome Measure Information:
Title
Timed 25 foot walk test (T25FWT)
Description
The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. Time to complete the T25FWT, and walking seed will be calculated. A lower time and faster walking speed indicates better walking performance
Time Frame
27 weeks
Title
Dynamic Gait Index (DGI)
Description
This scale has 8 conditions that an individual walks in (e.g. normal, head turns, change in speed, pivot, stairs). Performance for each condition is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best score on the DGI is 24, and a higher score means less walking impairment.
Time Frame
27 weeks
Secondary Outcome Measure Information:
Title
Multiple Sclerosis Impact Scale (MSIS-29)
Description
This is a 29 item self-reported questionnaire - 20 items deal with physical state and 9 with psychological. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where a larger number (e.g. closer to 100) indicates greater impact of disease on daily function.
Time Frame
27 weeks
Title
Fatigue Scale for Motor and Cognitive Functions
Description
This is a 20-item self-reported questionnaire, a Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). Two subscales (mental and physical fatigue) can be made as 10 questions relate to motor fatigue and 10 to cognitive fatigue. A higher score means the individuals is more affected by fatigue.
Time Frame
27 weeks
Title
Short From 36 Health Survey Questionnaire (SF-36)
Description
This is a self-reported questionnaire used to rate health related quality of life. Eight health concepts are covered in 36 questions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The 36 items are rated using a number of different scales and an intricate formula is used to calculate a final score. A high score defines a more favorable health state
Time Frame
27 weeks
Title
Multiple sclerosis walking scale - 12 item (MSWS-12)
Description
This is a 12 item self-reported questionnaire where participants rate each item from 1-5, giving a total out of 60, and then transforming this to a scale with a range from 0 to 100%.
Higher scores indicate a greater impact on walking than lower scores.
Time Frame
27 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
confirmed diagnosis of multiple sclerosis
gait deficit due to MS but still able to walk (EDSS less than 6.5, PDDS 3-6)
older than 18 and less than 70 years of age
agree to the study time commitment.
Exclusion Criteria:
currently attending physical rehabilitation for walking and/or balance training,
currently already functional community ambulators (gait speed>120cm/s)
contra-indications to the use of translingual electrical stimulation (active or suspected malignant tumor; recent bleeding or open wounds in mouth; women who are pregnant, or sensitivity to nickel, gold or copper)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Donkers
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle Ploughman
Organizational Affiliation
Memorial University of Newfoundland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 1E5
Country
Canada
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 2Z4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Neuromodulation in MS Using Translingual Stimulation
We'll reach out to this number within 24 hrs